Device for Gastric Feeding and Drainage Via an Artificial Stoma

ABSTRACT

The invention describes a closure device for the provision of freshly created gastric feeding fistulas, the basis of the design of the device being an introverted balloon that allows a sealing and hemostatic axial traction movement on the fistula that is to be sealed, the concentric balloon ends which run transmurally through the stomach and abdominal wall being arranged in a special seal-promoting and hemostatic manner.

PRIORITY

This patent application claims priority to currently copending GermanNational Application DE 10 2005 028 428.0 entitled “Vorrichtung zurgastrischen Ernährung und Drainage über eine transkutan angelegteFistel” filed on Jun. 17, 2005 by Microcuff, GmbH having Dr. Fred Göbelnamed as inventor.

BACKGROUND OF THE INVENTION

The present invention relates to a device for creating and maintainingan artificial stoma enabling access to a body cavity, such as used inthe direct feeding of a patient's stomach. More particularly, thepresent invention relates to a device for percutaneously placing variousgastric catheters, forming artificial stomas capable of accessing thegastrointestinal tract, and ultimately providing a gastric feedingcapability. Beyond the initial placement procedure, the device meets therequirements for permanent placement in the patient, such that when usedfor enteral feeding, the device enables a low-force, dynamicallyself-adjusting, directed seal between the inside of the stomach orgastric wall and an external body surface, i.e., the outside of theabdominal wall.

In particular, the invention addresses the problem of the seal orpermanent fusion of the tissues surrounding the stoma that needs to beestablished between the abdominal cavity and the inside of the stomachimmediately after the surgical creation of the fistula, i.e., during theinitial insertion of the catheter. It also is concerned with ways inwhich subsequent to placement, the catheter can be changed simply andatraumatically, even by a trained layperson, without damaging the stomasite.

It is recognized that numerous medical conditions exist in which itbecomes necessary to gain percutaneous access to viscera such as thestomach or small intestines. Situations where a patient has lost theability to swallow and will require long term nutritional support maydictate feeding directly into the stomach or jejunum. Feeding in thismanner may be accomplished by inserting a feeding tube into thepatient's stomach such that one end remains anchored in the stomach,while the other end remains external to the patient's body forconnection to a nutrient source. A variety of different feeding tubes orcatheters intended for enteral feeding have been developed over theyears, including some having a “low profile” relative to the patientduring use and those having the more traditional or non-low profileconfiguration.

Such feeding tubes may be inserted into a patient's stomach in a numberof ways. Feeding tubes may be endoscopically placed, surgically placedthrough an open incision, laproscopically placed, or percutaneouslyplaced under endoscopic, fluoroscopic or ultrasonic guidance. Differenttypes of feeding tubes may be placed using these procedures, examplesinclude gastrostomy, jejunostomy or gastro-jejunostomy. These tubes maybe retained in the lumen (stomach or intestine) with a variety ofretention anchors. These anchoring mechanisms include: inflatableballoons, obturatable domes, fixed dome-type bumpers, or suture wings.

It is known that many of the catheters on the market today are commonlyreferred to as “replacement” catheters because they are substituted foran enteral feeding tube that is initially placed in a patient for six toeight weeks until a fistula stoma tract is established. Once the stomatract is established, the initial placement device is generally removed,and the “replacement” enteral feeding device is inserted into the stomatract. Historically, prior to placing the actual enteral feeding device,it has been preferred to perform a gastropexy procedure duringplacement. This procedure enables the physician to attach the visceralwall to the abdomen and to create the stoma tract through the two. Thisattachment is critical to prevent inadvertent separation and exposure ofthe peritoneal cavity to contamination and possible peritonitis.

Initial placement devices are often not readily removable withoutadditional invasive surgical procedures. That is, many initially placedenteral catheters contain rigid retention members which cannot readilybe passed through the stoma of the patient when it is desired to removethe initially placed device. Typically the t-shaped fastener or t-bar isnot removable and is left in the body cavity where it is allowed to passnaturally in the patient's stool. In many cases the t-bar is not passedand remains within the body cavity. Moreover, during the six to eightweeks it takes for the fistula's stoma tract to be established, theanchoring mechanism of the prior art gastropexy device which typicallyconsists of a small metal t-shaped fastener may embed itself into thegastric or intestinal wall and ultimately lead to infection.Furthermore, the t-bar itself may have sharp edges which can beuncomfortable for the patient.

In many of these procedures, in order to achieve the desired sealbetween the stomach and the abdominal wall, a traction force must beapplied to the anchoring mechanism. The force is applied in such a wayas to pull the stomach cavity to the abdominal wall so that thepenetration through both may heal together thereby creating the passageor stoma leading from the patient's stomach, through the abdominal wall,to an external environment. It is necessary to apply this traction forcefor a period of a couple of days through a couple of weeks until thestoma site adequately heals. During this period the patient has reducedmobility which may lead to additional post-operative complications.

There is a need and desire for a device which may be used during initialplacement or creation of a stoma site and which also may serve as the“replacement” enteral feeding device itself. Such a device would fosterthe permanent fusion of the stomach wall to the abdomen; it wouldreplace standard catheter placement technology and thus substitute asingle step procedure for the standard multi-step procedure. This wouldserve to reduce the invasiveness of the procedure, greatly enhance woundhealing, and enable immediate, post-placement gastric access for feedingand drainage, and ultimately allow atraumatic exchange of the lowprofile device.

SUMMARY OF THE INVENTION

In response to the foregoing problems and difficulties encountered bythose of skill in the art, the present invention is directed toward adevice for the creation of an artificial stoma into and subsequent fluidtransfer to or from a living body. Such a device may provide thefollowing advantages: it would foster approximation of the gastric walland abdominal wall in a sufficiently large area to enable tissue fusion;it would reduce the number of punctures to only one transcutaneousgastric puncture or incision; it would create a self-adjusting seal withrespect to the puncture site and do so while taking into account bodymovement and resulting sheer forces; it would provide secure anchoringeven under high pull-forces; it would reduce or prevent initial leakageor bleeding from the puncture channel thus reducing the likelihood ofperitoneal infections; it would allow immediate access to the stomachand maintain the initial and continuous dilation of the puncturechannel; it would reduce the risk of ulceration within the gastric lumendue to low-pressure filling of the balloon; it would enable enhancedpatient mobility and comfort; and it would provide one device, meetingthe requirements of both initial and long-term placement.

The above-mentioned problems and difficulties can be solved by a deviceaccording to independent claim 1. Further advantageous features, aspectsand details of the invention are evident from the dependent claims, thedescription, and the drawings.

The device in one embodiment would include a thin foil having a firstand a second end with a length disposed therebetween. The thin foilwould be arranged in a manner such that one of said ends is backfoldedor introverted into the other of said ends. A cap having at least oneport therethrough would also be provided. The cap would securely captureeach end of the foil. The port would terminate between the first andsecond foil ends within a space created by introversion of the foil. Byapplication of an inflation source to the port, the length of the foilwould inflate and form a generally torus shaped balloon having bothexterior and interior externally facing concentric surfaces. The cap issituated at one end of the balloon.

In many embodiments, the device would contain a bore through the cap sothat communication with a passage formed by the interior externallyfacing surface may be had. Such communication would pass through theinterior of the device. In many embodiments, the torus shaped balloonmay be adapted to exert an increasingly greater force upon increasinginflation, the force being exerted axially along the foil and directedtoward the cap.

Some embodiments may be provided with an insertion device used forplacing the foil in a deflated state within the living body andsituating the cap adjacent a body surface at the stoma. The insertiondevice may contain a user manipulable introducer and a capturingelement. The introducer may be configured as a tapered probe having acavity therein within which the foil is temporarily captured. Thecapturing element would be sized to fit frictionally within the bore andin conjunction with the foil would retain the introducer in positionproximate to the cap. An extension rod may be affixed to the introducer.The extension rod would enable the tapered probe to be inserted deeperinto the living body until the foil is disengaged from within thecavity. This could be accomplished without affecting the position of thecap or the capturing element. To remove the introducer, the balloon isinflated and the introducer is extracted from the living body by passingit out via the passage and bore, again, subsequent to inflation of theballoon and removal of the capturing element.

The device in any of its embodiments may be adapted to be placed in theliving body by engaging a guide wire previously situated in the livingbody, a process known and understood by those of skill in the art.

According to one specific embodiment, the present invention relates to adevice for supplying patients by means of a transcutaneous fistula(stoma) for direct feeding into the stomach, comprising a balloon whichis backfolded in itself, whereby the inner end of the balloon serves asan open lumen for inserting a feeding catheter therethrough, wherebymoreover an axially oriented tractive force acts between the balloon andthe ends of the balloon, which causes a force component pressing theinner abdominal wall onto the stomach, and whereby on the body surface adisc element and/or a diameter of the outer one of the two concentricends of the balloon, enlarged at least about 25% compared to the ratioof the diameter of the fistula, serves as a bearing for an axiallyoriented back rolling of a torus onto the inner stomach wall.Specifically, the diameter of the outer of the two concentric ends ofthe balloon may be larger than about 50 to about 75% of the fistula.

Other objects, advantages and applications of the present invention willbe made clear by the following detailed description of a preferredembodiment of the invention and the accompanying drawings whereinreference numerals refer to like or equivalent structures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an illustrative view of one embodiment of the presentinvention.

FIGS. 2 and 3 depict intermediate steps in the creation of thebackfolding principle described in many of the embodiments of thepresent invention.

FIG. 4 depicts an alternative embodiment of the FIG. 1 device.

FIG. 5 depicts an alternative embodiment of the FIG. 1 device having asecond embodiment of a useful retention mechanism.

FIGS. 6 and 7 depict further embodiments of the device incorporatingfeatures from the FIG. 1 device as well as the second embodiment ofretention mechanism.

FIG. 8 depicts yet another embodiment of the device incorporating athird embodiment of the retention mechanism.

FIG. 9 depicts an insertion device adapted to be used with the FIG. 8embodiment.

FIG. 10 depicts a channel enabling venting of the device; such a channelmay be used on any embodiment of the device described herein.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

In response to the foregoing challenges that have been experienced bythose of skill in the art, the present invention is directed towardmaking initial feeding catheter placement less invasive and morecomfortable for the patient. The invention is intended to reducecomplications associated with enteral feeding and the initial placementof the enteral feeding device such as bleeding or leakage of gastricfluids. It provides a single device capable of accommodating both theprocedure of placement and long-term wear and use which addresses theneeds associated with initial as well as prolonged placement of thecatheter.

To solve these problems, the invention envisions an introverted orbackfolded balloon arrangement similar to that described, in a basicform, in WO 2004/069057 to Dr. Lothar Göbel, which is incorporated fullyherein by reference. It should be understood that the introversion ofone end of a balloon element through the opposite end produces a “torus”shape. In the inflated state, this torus structure has the tendency tomove the balloon ends into a median plane of the torus ring. A tractiveforce operates axially between the balloon and the balloon ends, thusserving, in the present invention, as an important basic functionalelement.

If the balloon ends are passed through the fistula channel and securedoutside the body on the outside wall of the abdomen within a fixing capelement, the resulting axial tractive force would generate a forcecomponent capable of pressing the stomach against the inside wall of theabdomen. This would permit the permanent fusion of the two tissue layerswhich prior to this device would have necessitated a separate treatmentstep prior to the actual placement of the enteral feeding device andintra-gastric access channel through the fused tissue. This torus shapedclosing element would also allow immediate access to the stomach througha free central lumen of the element. This lumen may be used forimmediate feeding, drainage or insertion of a catheter therethrough.

An initial version as well as alternative embodiments of such a devicehas been described in DE 10 2005 028 428.0 entitled “Vorrichtung zurgastrischen Ernährung und Drainage über eine transkutan angelegteFistel” and was filed on Jun. 17, 2005 by Dr. Fred Göbel. As such, thisdisclosure is also fully incorporated herein by reference and thisapplication claims priority thereto.

Looking now to FIG. 1, a device 10 in accordance with the presentinvention is depicted. FIG. 1 depicts the spatial relationships betweenthe device 10 and the adjacent organs to it: the gastric wall 12, theabdominal wall 14 and the anatomical fusion site 16 between the two wallstructures 12 and 14, where the perforation forming the fistula or stoma18, in a patient's living body 20, is situated. At this point, it shouldbe understood that for convenience the description of the device willgenerally be directed toward accessing the stomach, for example, toenterally feed a patient. However, the devices as shown and describedherein may also be used to create a communication between two cavitylocated organs, spaces or structures, or one cavity located organ, spaceor structure and an external environment. As such, no limitationsspecifically requiring the invention to be associated with enteralfeeding or gastric access should be read into the specification.

In many of the contemplated embodiments, the device 10 is formed from athin foil 22 having first and second ends 24 and 26 respectively. Asshown in FIG. 2, the foil 22 may be cylindrical in shape and have alength 28 disposed between the ends 24 and 26, which along with the endsmay define a three-dimensional volumetric space bounded by a surface orsurfaces formed by the foil itself. Among the simplest of volumetricspaces is the cylinder, as shown. However, other contemplated volumetricshapes may include the sphere, cube, cone, cylinder, and more generally,the polyhedra.

In common embodiments, and referring to the cylindrical embodiment ofFIG. 2 in particular, FIG. 3 depicts one of the ends of the foil 22being backfolded or introverted into the other, for example, end 26 maybe backfolded into end 24 such that end 26 is situated within end 24. Ofcourse, this configuration may be switched with end 24 situated withinend 26 and still perform in accordance with the invention.

In any event turning back to FIG. 1, it may be seen that by capturingthe ends 24 and 26 within a cap 30, an interior space 32 is created.This space 32 is created by the introversion of the foil 22 itself andmay be seen to be defined by its length 28 and bounded by its ends 24and 26. Providing the cap 30 with a port 34 that terminates within thisspace 32 between the first foil end 24 and the second foil end 26creates a torus shaped structure or balloon 36 having exterior andinterior externally facing surfaces 38 and 40 respectively. The space 32forms the interior of the balloon 36 and is adapted to inflate anddeflate upon application or removal of a fluid source such as air,water, or saline. Other fluids may be used and would be understood bythose of skill in the art.

The surface 38 may be seen to be an externally facing, exterior surfaceof the balloon 36. The surface 40 is also an exterior surface, however,it is considered an internally facing, exterior surface of the balloonin that it forms a passage 42 through the center of the torus shapedballoon yet does not enter the space 32. The diameter of this passage 42formed by the surface 40 in many embodiments is smaller than thepuncture channel through the gastric 12 and abdominal wall 14. Thediameter of the passage 42 determines the flow-characteristics throughthe device. Further, secondary catheter elements, described below, maybe inserted into the passage 42 if desired.

In order to inflate the balloon 36, an inflation source or mechanism 44of some kind should be capable of connection to the port 34. As statedabove, the fluid used to inflate the balloon 36 may be a suitable gas orliquid, such as air or saline. A retention mechanism 46 may also beprovided in order to hold the device 10 properly within the living body20. Such a retention mechanism 46 is envisioned to have numerouspossible configurations each of which will be discussed at greaterlength in this specification. In a first embodiment, the retentionmechanism 46 may be configured as a simple disc, button, or retainingring 48. The retaining ring 48 may be secured to the cap 30 or to theballoon 36 itself via a friction fit and may simply be adapted toslidably attach to the exterior of the device in some manner so that itmay be slid against the skin of the abdominal wall of the patient whenin place.

A bore 50 through the cap 30 connects the passage 42 to an externalenvironment. The bore 50 forms an opening through which fluids may passinto or out of the living body 20. In many embodiments, the bore 50enables the injection of enteral feeding solutions. It may also be usedto vent gases or other fluids from within the cavity as described inmore derail below. However, in any of the embodiments described,dedicated pathways may be provided, one for feeding and one for venting.This concept would be readily understood by those of skill in the artand may be accommodated by numerous configurations including but notlimited to the insertion of a dedicated catheter 52 through the bore 50,through the passage 42, and into the stomach or other organ within whichthe device is in communication. Such a catheter may be seen in FIGS. 5through 7 which will be further described below. The catheter 52 mayhave dual lumens, one for feeding and one for venting. Alternatively,the catheter 52 may be used for one of the functions whereas the otherfunction is performed by ensuring that there is ample room between theexterior of the catheter and the passage 42 and/or bore 50 diameters.

Referring generally back to this principle of an introverted foil 22forming a torus shaped balloon 36, it may be seen that this is animprovement over the prior art devices currently in existence. Forexample, it should be noted that the present device 10 forms a shaftlesscatheter structure which effectively eliminates the need for the priorart rigid shaft elements. It should also be understood by those of skillin the art that unlike a balloon bearing a rigid shaft, the presentinvention may be reduced to a collapsed tape-like structure when in thedeflated and evacuated state. With such a device 10, it would bepossible to insert the balloon portion 36 through the stoma 18 and intothe living body 20 via a low-invasive, small bore access penetration.

Furthermore, due to the controllable collapsibility of the device 10 itis more amenable to atraumatic removal from the stoma than are prior artdevices. This is because the present invention does not require thesignificant trans-abdominal exertion typically associated with thoseprior art devices containing a rigid shaft element for carrying theballoon component. In the prior art devices, the mechanics of theballoon member are typically altered negatively over time, for example,balloon members associated with the prior art are known to stiffen andlose their ability to retract fully into the shaft completely. Thisresults in the creation of traumatizing folds that may exacerbatehealing of the stoma site upon removal or subsequent manipulation of thecatheter.

Turning now to FIG. 4, it may be seen that by giving the trans-abdominalsection, i.e., that portion of the balloon 36 that is in contact withthe stoma site 18, appropriate dimensions, the device 10 when inflatedmay be enabled to produce a certain radial force onto thetrans-abdominal structures of the surgically perforated fistula channelor stoma 18. This force would serve to keep the penetration channelunder permanent expansion and would therefore provide an efficient sealagainst gastric material leaving the stomach and entering the peritonealcavity between the stomach and abdominal wall 14. Moreover this featurecould also slow or stop bleeding at the site and foster a permanent andcontinuous dilation of the stoma itself.

Continuing to look at FIG. 4, it ma_(y) be seen that the outer of thetwo concentric foil ends, in this case end 24 is dimensioned in such away, that the exterior surface 38 exceeds the diameter of the stomaperforation. This may be seen by viewing that portion of the exteriorsurface 38 in contact with the gastric wall 12. In many embodiments, thesurface 38 may be made to exceed the stoma diameter by a significantamount. A significant amount may be thought of in general terms as anamount that exceeds the widest section of the perforation by at leastabout 10%, but may range significantly higher including ranges fromabout 25 to about 50% greater than the stoma diameter, and in someembodiments may range up to about 75% greater than the stoma diameter.

Due to the material selection of the balloon, the mechanical propertiesof the material, and the balloon's wall thickness, the device 10 may bedesigned to function at inflation pressures that inhibit bleeding in thestoma 18 without subjecting the foil to a tensive or extensive force.That is, the rest of the sheath, introverted in the transmural passagearea, forms a tight closure in this section of the device by virtue ofthe proposed material wall thickness, discussed in greater detail below.This serves to prevent the escape of gastric secretions in spite oflongitudinal folding of the exterior surface 38. Hemostatic inflation ofthe device 10 precisely tailored to the particular blood flow situationcan thus be achieved in the area of the stoma perforation. Whenthin-walled balloon membranes with a residual dimension are used, thetransmural force which the balloon exerts on the puncture channelcorresponds largely to the inflation pressure measurable in the case inquestion.

In order to promote this radial expansion effect, the wall thickness ofthe balloon 36 would likely be no greater than about 100 micrometers,especially in those regions where radial expansion is desirable, such asat the trans-abdominal section. Even so, in many embodiments, theballoon may be made of a soft membrane having a wall thickness of fromabout 30 to about 60 micrometers. While devices having wall thicknessesin this particular range are well-suited for use as initial placementdevices, where higher seal forces are desired, a structurally identicaldevice which is anticipated to remain in place for long-term treatmentcould be made of even thinner walled, less pressure resistant materials.In such devices, it is envisioned that the outer or exterior surface 38especially at the trans-abdominal region would not even exceed about 50micrometers, and may actually be thinner, in the range of from about 10to about 30 micrometers.

A material capable of functioning in the prescribed manner and capableof functioning with these wall thicknesses may be manufactured ofPellethane 2363 from DOW Chemical, a thermoplastic polyurethane.However, other materials having similar mechanical characteristicsshould work equally as well. Suitable materials would be mechanicallylow-compliant and therefore stable in shape under elevated balloonfilling pressures. They would exhibit little volume expansibility, andas such, as in the example stated above, a polyurethane is particularlywell-suited in this application. Such materials, even under heavytraction, would not permit any considerable shape deformation of thetorus balloon and thus would minimize the possibility that the ballooncould inadvertently slip through the gastric wall. This capability is ofsome importance so as to ensure the continued reliability of the deviceunder conditions associated with daily use.

FIG. 5 depicts an alternative embodiment of the device 10 having a bulge54, in this case a disc-shaped bulge, formed into the exterior surface38 of the balloon 36. This bulge 54, if present, would desirably besituated proximate to the end 24 such that it would be external to thestoma 18 and the living body 20 itself. The bulge 54 would serve as asecond embodiment of the retention mechanism 46 and it may be seen thatsuch a feature would counteract the force associated with the torussection of the balloon 36 internal to the living body 20. Thisembodiment may further facilitate homeostasis in the superficial woundarea immediately after the perforation of the stoma 18. Moreover, thebulge 54 may also be desirable when a more rigid retention mechanism 46can not be used due to the development of ulcers or other irritations ofthe skin.

In any of the aforementioned embodiments as well as in furtherembodiments described below, the foil 22 may be designed so that in thefreely deployed state, that is, when the pressure within the space 32 isequal to the ambient environmental pressure, the exterior surface 38 ofthe balloon 36 at the trans-abdominal region may have a residualdiameter which allows for the infolding of that surface 38 and thusprovides for the best possible equalization of acting force and measuredinflation pressure.

Turning now to FIG. 6, it may be seen that a version of the device 10may be manufactured so as to place a secondary bulge 56 between thegastric wall 12 and the abdominal wall 14. Such a device 10 would serveas a bolster against the intra-gastric balloon 36, and thus would enablea fluid tight seal and/or a haemostatic compression against gastricperforation when the balloon 36 and secondary bulge 56 were inflated.This may be of use, for example, in situations in which a patient hassuffered a severe perforation and its associated bleeding. The device ofFIG. 6 would enable the clinician to perform efficient compression ofthe puncture site. That portion of the device which would serve as theanchor or retention mechanism external to the living body 20 may consistof the bulge 54 or of a retention mechanism 46 similar to that shown inFIG. 1 or 4.

FIG. 7 shows yet a further alternative version of the device 10. TheFIG. 7 embodiment depicts the torus shaped balloon 36 portion as beingestablished inside the gastric wall 12 yet has no direct anchoringcapability outside the abdominal wall 14. Such an intra-abdominal devicegrants free abdominal movement of the perforated organ and would alsoenable gastric access, yet the gastric wall 12 and the abdominal wall 14would not be brought into direct contact and would thus not fuse to oneanother. This may be desirable for some medical or anatomical reasons.In this example, the device would be connected to the body outsidethrough a hose connection.

As shown in FIGS. 5 through 7 the catheter may be used in any of theembodiments, including the others described herein. In particular,having the ability to slide a catheter 52 through the bore 50 andpassage 42 into the stomach or other site internal to the living body 20would be beneficial in cases of long-term use, as the catheter 52 couldbe changed simply and atraumatically, i.e. without damaging the puncturechannel, and it could be accomplished even by a trained layperson.

Referring to FIG. 8 there is shown a cross-sectional view of stillanother embodiment of the present invention. This embodiment is similarto the previous embodiments in that the balloon 36 may be configuredsimilarly to any of the balloon embodiments described above. Like theprior embodiments, the FIG. 8 embodiment includes the thin foil 22having a length 28 terminating in the first and second ends 24 and 26.Additionally, one end is backfolded or introverted with respect to theother so as to create the space 32 that forms the balloon 36 between thetwo ends 24 and 26 respectively. However, FIG. 8 depicts yet a thirdembodiment of the retention mechanism 46. In that FIG. 8 forms a moredetailed cross-sectional view of one possible embodiment, a number ofitems are described as pertaining to FIG. 8. It should be noted thatthese items may also be found on other embodiments, including thosedescribed above. Those items not capable of being utilized on previousembodiments will be specifically noted.

In more general terms, this embodiment integrates the retentionmechanism 46 into the cap 30 itself. As such, the two components may bethought of as forming a head 58. The head 58 serves at least in part tocapture the ends 24 and 26 but also serves to contain a valve or valveswhich are used to regulate the flow of fluids through the entire device10. As such, the head 58 may be made of a medical grade silicone butshould be sufficiently designed to capture the foil ends 24 and 26without undue failure. As is the case with each embodiment of theretention mechanism 46, the head 58 also serves to prevent the device 10from completely advancing through the stoma 18 and into the stomach orintestine of the living body 20.

A first of said valves would serve as the port 34 and as such would beadapted to couple the space 32 with the inflation source or mechanism44. As in the previous embodiments, the port 34 would serve as a meansto inject fluids into or remove fluids from the space 32 forming theinterior of the balloon 36. A lumen 60 may be provided that leads fromthe port 34 to the space 32. Such a lumen 60 though not shown may bedesirable on each of the other embodiments. As would be apparent,control of the inflation mechanism 44 through the port 34 enables theuser or a physician, etc., to selectively control inflation anddeflation of the balloon 36. To assist in this, a releasable one-wayvalve 62 may be disposed between the space 32 and the port 34, forexample in the lumen 60. Appropriate valves capable of serving in thisfunction are known and would be understood by those having skill in theart and may be actuated by means of a syringe.

A second of said valves, if provided, may be situated in the bore 50located in the head 58 and would enable the injection of enteral feedingsolution, etc., through the device 10 and into the user. The valve maycomprise an anti-reflux valve 64 which is configured to allow nutrientsolutions, etc., to pass into the user, but to prevent the flow offluids out of the user unless properly engaged by a syringe or othersampling device having a nipple which corresponds to the anti-refluxvalve. The anti-reflux valve 64 would be disposed such that it is incommunication with the passage 42.

Looking now to FIG. 9, the FIG. 8 embodiment is depicted in conjunctionwith an insertion device 66. The insertion device 66 may be configuredas a user manipulable introducer 68 having a hollow probe 70 at one end.The probe 70 may be tapered at a distal end 72 to allow ease of passagethrough the stoma 18 so as to minimize aggravation of the tissue. Aproximal end 74 of the probe 70 may also be tapered to allow subsequentwithdrawal of the probe 70 from the stoma 18 with minimal tissue damageas well. Protruding from the proximal end 74 is an extension rod 76adapted to be grasped by the user, physician, or clinician. The rod 76may be configured as a hollow cannula so as to be deployable over aguide wire (not shown) previously placed within the living body 20.

Prior to installation in the living body 20, the foil 22 is capturedwithin a cavity 78 formed in the hollow probe 70. The extension rod 76is situated so as to extend from the cavity 78, through the passage 42and the bore 50, and ultimately extend outward through the head 58. Acapturing element 80 is designed to be slid over the extension rod 76and seated within the bore 50 in the head 58. By ensuring that thecapturing element 80 is held in contact with the foil 22, which in turnis pressed against proximal end 74 of the probe 70, the insertion device66 may be placed in situ within the cavity.

Once the foil 22 is in place, the user would continue to advance theprobe 70 deeper into the living body 20 until the foil 22 is adequatelydeployed from the cavity 78. Prior to or during this step, the capturingelement 80 may be removed from the extension rod 76 or at least backedaway from the probe 70. This may all be accomplished by manipulation ofthe extension rod 76. Subsequent inflation of the balloon 36 wouldensure that the foil 22 is completely free of the cavity 78. After theballoon 36 is inflated, the probe 70 may be withdrawn from the livingbody by backing it out through the passage 42 and the bore 50, andultimately completely removing it from the device 10.

Finally, FIG. 10 has been included to address ventilation of the livingbody 20. In FIG. 10, it may be seen that the channel 42 contained withinthe balloon 36 may be shaped in order to prevent its total collapse intothe tapelike structure. That is, by manufacturing the end 26 as well asa portion of the interior surface 40 to a given foil wall thickness, onecan prevent a total collapse of the channel 42, and instead it ispossible to form one or more laterally positioned tubular paths 82.These tubular paths 82 would serve to grant a permanent, noncollapsiblepassageway for gases. The diameter of the resulting tubular paths 82 maybe configured by choosing an appropriate wall thickness of the foil 22.Alternatively a tubular reinforcement exhibiting an appropriatestiffness may be inserted and permanently affixed within the channel 42.This may be desirable in instances as described above where a patienthaving an existing anatomical or functionally insufficient communicationbetween the stomach and the ambient surrounding of the patient requiresthe release of accumulating stomach gases

As used herein and in the claims, the term “comprising” is inclusive oropen-ended and does not exclude additional unrecited elements,compositional components, or method steps.

While various patents have been incorporated herein by reference, to theextent there is any inconsistency between incorporated material and thatof the written specification, the written specification shall control.In addition, while the invention has been described in detail withrespect to specific embodiments thereof, it will be apparent to thoseskilled in the art that various alterations, modifications and otherchanges may be made to the invention without departing from the spiritand scope of the present invention. It is therefore intended that theclaims cover all such modifications, alterations and other changesencompassed by the appended claims.

1. A device (10) for the creation of an artificial stoma (18) into aliving body (20) comprising: a thin foil (22) having a first and asecond end (24, 26) with a length (28) disposed therebetween, the thinfoil (22) being arranged in a manner such that one of said ends isbackfolded or introverted into the other of said ends, the thin foil(22) further characterized as formed of a material that exhibits littlevolume expansibility such that it is stable in shape under elevatedballoon filling pressures; and a cap (30) having at least one port (34)therethrough, the cap (30) securely capturing each end (24, 26) of thefoil (22) therein, the port terminating between the first and secondfoil ends (24, 26) within a space (32) created by introversion of thefoil (22) so that application of an inflation source (44) to the port(34) causes the length (28) of said foil (22) to inflate and form agenerally torus shaped balloon (36) having exterior and interiorexternally facing concentric surfaces (38, 40) such that that theinterior facing surface (40) defines a passage (42) through the device;and wherein a bulge (54) is formed into the exterior surface (38) uponinflation of the balloon (36), the bulge (54) being proximate the end(24) of the foil (22) and adjacent the cap (30) securing each end(24,26) of the foil (22).
 2. The device (10) of claim 1 wherein thetorus shaped balloon (36) is adapted to exert an increasingly greaterforce upon increasing inflation, the force being exerted axially alongthe foil (22) and directed toward the cap (30).
 3. The device (10) ofclaim 1 adapted to be placed in the living body (20) by engaging a guidewire previously situated in the living body (20).
 4. The device (10) ofclaim 1, wherein the thin foil (22) is made of a mechanicallylow-compliant material.
 5. The device (10) of claim 1, wherein the thinfoil (22) is made of a thermoplastic polyurethane.
 6. The device (10) ofclaim 1, wherein the exterior surface (38) exceeds the diameter of thewidest section of the artificial stoma (18) perforation by at leastabout 10%.
 7. The device (10) of claim 1, wherein the exterior surface(38) exceeds the diameter of the widest section of the artificial stoma(18) perforation by an amount ranging from about 25% to about 50%. 8.The device (10) of claim 1, wherein the exterior surface (38) exceedsthe diameter of the widest section of the artificial stoma (18)perforation by an amount up to about 75%.